人脐静脉内皮细胞增殖抑制法检测贝伐珠单抗活性的优化和应用

发布时间：2018-02-07 17:42

本文关键词： 血管内皮细胞生长因子单抗生物学活性质量控制　出处：《中国新药杂志》2015年20期 　论文类型：期刊论文

【摘要】：目的:优化人脐静脉内皮细胞(human umbilical vein endothelial cells,HUVEC)增殖抑制法,并用优化后方法比较6种贝伐珠单抗(bevacizumab)生物类似药(similar bio-therapeutic products,SBPs)候选药物与原研药的生物学活性。方法:对细胞接种量、VEGF165浓度和样品稀释浓度进行优化,提高方法精密性和准确性。使用优化后的方法,以贝伐珠单抗为参比品,测定6种贝伐珠SBPs的生物学活性,并与原研药进行比较。结果:优化后的HUVEC增殖抑制法,信噪比为1.5~1.8,板间变异度20%,在70%~130%活性范围内有良好的准确性。使用优化后方法检测,质控样品的相对活性均值为102.00%,6种贝伐珠SBPs的相对活性分别为95.12%,88.81%,96.96%,103.00%,105.70%和102.40%。结论:通过优化,HUVEC增殖抑制法的精密性和准确性较经典方法有显著提高,适用于贝伐珠单抗及其SBPs的可比性评价。
[Abstract]:Objective: to optimize the proliferation inhibition assay of human umbilical vein endothelial cells in human umbilical vein endothelial cells (HUVECs). The biological activities of six similar bio-therapeutic products SBPswere compared with those of the original drug by the optimized method. Methods: the concentration of VEGF165 and the dilution concentration of VEGF165 were optimized. To improve the precision and accuracy of the method, the biological activity of six bevacizus SBPs was determined by using the optimized method with bevacizumab as reference product, and compared with the original drug. Results: the optimized method was used to inhibit the proliferation of HUVEC. The signal-to-noise ratio (SNR) is 1.5 ~ 1.8, and the inter-plate variability is 20%. It has good accuracy in the activity range of 70% and 130%. The average relative activity of the quality control samples was 102.00. The relative activity of the six bevacious beads SBPs was 95.128.81 and 96.966.96, 105.70% and 102.400.Conclusion: the accuracy and accuracy of the SBPs method were significantly higher than that of the classical method. It is suitable for the comparative evaluation of bevacizumab and its SBPs.
【作者单位】：中国食品药品检定研究院单克隆抗体产品室;
【基金】：国家“重大新药创制”科技重大专项(2014ZX09304311-001)
【分类号】：R927

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